March 18, 1998
Health Group Files Suit Over NIH Experiments on HIV-Positive Women in Developing Countries
NIH Fails to Produce Consent Forms and other Documents for Unethical Experiments on Pregnant Women
Public Citizen today filed suit in the Federal District Court for the District of Columbia against the National Institutes of Health (NIH) to compel the agency to produce records detailing its controversial and unethical placebo-controlled experiments on HIV-positive pregnant women in developing countries.
For over a year, Public Citizen has been waging a campaign against over a dozen studies in developing countries, most funded by the Center for Disease Control and NIH, that denied HIV-positive pregnant women access to AZT, a drug that reduces mother-to-infant HIV transmission by two-thirds. About 1000 babies are expected to die needlessly in these experiments.
The pregnant women were supposed to have agreed to become subjects of the experiments by signing informed consent forms, but the NIH is unable or unwilling to produce these forms for studies in Ethiopia, Tanzania and Uganda.
“NIH?s claim that it cannot find the protocols and informed consent sheets for these multi-million dollar experiments defies belief. What is the NIH covering up, and why?” said Dr Sidney Wolfe, Director of Public Citizen?s Health Research Group. Public Citizen originally asked NIH for these documents almost a year ago, on April 29, 1997.
The NIH also has failed to produce crucial information on the drug protocols used in the experiments and other material about the design of the studies. The complaint filed today by Public Citizen is to compel NIH to produce the documents it is withholding on the experiments.
“Exactly how much these African and Asian women knew about what they were getting into isn?t clear,” said Dr. Wolfe. “The NIH has a moral responsibility to show that people signing up for these deadly experiments really were fully informed about their dangers, including the fact that NIH knew of evidence, four years ago, suggesting that a moderately short course of AZT worked significantly better than a placebo.”
Public Citizen, several leading medical ethicists and the New England Journal of Medicine opposed the placebo-controlled experiments on the grounds that researchers are obligated to provide patients with the best proven therapy. Since April 1997, Public Citizen has recommended that the studies be redesigned to compare shorter regimens of AZT to the longer ones (rather than to placebos), a design called an equivalency study. With the finding, last month, that a CDC-funded study in Thailand had confirmed that a four-week course of AZT did work better than a placebo in reducing maternal-infant HIV transmission, the government announced that all women in placebo arms of the various studies would be offered AZT.